Method Development and Validation for the estimation of Class-2 Residual Solvents in Valacyclovir by HS-GC

Abstract

A simple headspace gas chromatographic (HS-GC) is a novel approach for the simultaneous detection of residual solvents such as ethanol has been devised and validated. Valacyclovir in ethanol, acetone, isopropyl alcohol, toluene, and acetic acid utilizing nitrogen as the carrier gas at a 4 mL/min flow rate with DB-620 column (80mx0.22mm) 1.8m inner diameter by using a flame ionization detector (FID). The headspace gas chromatographic technique provides an acceptable symmetry and resolution for all these residual solvents. The suggested method was shown to be satisfactory for determining the residual solvents of five distinct types. The method's validation findings showed that it is specific, exact, accurate, rugged, linear, and robust, with recoveries ranging from 80-120%. The %RSD (Relative Standard Deviation) for six injections should be NMT-10%. The correlation coefficient R2 ≥ 0.999.